The field of endoscopic surgery is a dynamic area in which major advances in both surgical procedures and instrumentation are occurring. Endoscopic surgical procedures are gaining wide acceptance among the medical profession, health care insurers, and patients because of the many advantages associated with the employment of these procedures. One major advantage is that any incisions which have to be made into the fascia and musculature of a patient in order to perform an endoscopic surgical procedure are of de minimis size in comparison with the radical incisions required in conventional, open surgical techniques. Endoscopic surgical procedures not only reduce the trauma to the patient, but result in reduced avenues for infection and improved rates of recovery. It is not unusual for patients undergoing endoscopic procedures to be either treated on an out-patient basis, or to leave the hospital after a one or two day stay. In contrast, procedures involving conventional, open surgical techniques wherein major, radical, incisions are made in order to access a body cavity or joint, such as a knee, require lengthy recuperative post-operative stays because of the trauma resulting from the radical surgical procedures. In addition, it can be appreciated that during conventional surgical procedures, the avenues for infection are greatly increased, and the interior sections of the body where the procedure is being performed are stressed by being unnaturally exposed to a foreign environment of both ambient air and ambient contaminants.
It is common to perform endoscopic surgical procedures by initially inserting a trocar assembly through the fascia and musculature of the patient in order to access the internal operative site such as the abdominal cavity. The trocar assembly typically comprises an elongated obturator having a sharp tip for piercing. The obturator is concentrically housed within a cylindrical cannula tube. After insertion, the obturator is removed from the cannula tube thereby providing a pathway to the interior of the patient through the cannula tube. Numerous endoscopic surgical instruments can be inserted through the trocar cannula including endoscopic fiber optic light pathways, surgical staplers, cutting and ligating instruments and the like. As with all surgery, it is often necessary to suture incisions made during the endoscopic operative procedure. In order to facilitate suturing, surgical needle and suture and cannula assemblies have been developed. The assemblies typically consist of a surgical needle having one end of a suture affixed thereto. The other end of the suture is run through a cannula and is affixed to the proximal end of the cannula. During surgery, the surgeon grasps the needle and suture using endoscopic surgical grasping instruments and inserts the needle and suture through a trocar cannula to the operative site. There, the needle and suture can be inserted into and out of tissue; e.g., at either side of an incision. Then the needle is grasped by the grasping instrument and withdrawn along with a length of suture from the patient through the trocar cannula. Exterior to the patient, the surgeon places a knot in the suture by manipulating both ends of the suture. Once the knot has been tied and the needle has been cut from the suture, the proximal end of the cannula is broken, allowing the cannula to be displaced or slide with respect to the suture. The cannula is then used as a knot pusher to push the knot through the trocar cannula along the suture into the interior of the patient and to the operative site to securely knot the suture, thus completing the desired suturing function such as joining tissue, ligating vessels and the like. The suture is then cut and the excess suture and cannula are removed from the patient.
It is extremely important that the needle and suture and cannula assembly be packaged in a manner such that the suture material is retained in a fairly straight configuration. It is also important that the cannula and suture and needle assembly be held and retained in a manner such that it will not be damaged during sterilization procedures, packaging, handling and storage. It is also important that the cannula and suture and needle assembly be readily and easily removable from the package in an essentially continuous motion without damage to the device.
Packages for needle and suture and cannula assemblies are known in the art, however, these packages have several disadvantages. First of all, the packages tend to allow the suture material to move about the package during shipping, handling, and sterilization procedures, thereby allowing the suture material to become kinked or otherwise misshaped and, therefore undesirable for use in endoscopic surgical procedures. In addition, it is very difficult for operating room personnel to remove the cannula and needle and suture assembly in an easy manner from the prior art packages. Finally, these packages do not prevent the inadvertent tearing or puncturing of a plastic overwrap by the cannula which can occur as a result of mishandling of the packaged device.
What is needed in this art is a foldable package for a surgical needle and suture and cannula assembly used in endoscopic surgical procedures which protects and retains the needle and suture and cannula, but yet allows for easy removal of the suture and needle and cannula from the package.